Medical containers for use in blood collection and processing and medical systems, methods and apparatus for use in blood collection and processing
Medical containers for use in blood collection and processing and medical systems, methods and apparatus for use in blood collection and processing are described. An example medical container to be used during blood collection and processing, the medical container includes an elongated body defining a compartment and a base coupled at a first end of the elongated body. Additionally, the medical container includes a divider extending through the compartment to separate the compartment into a first subcompartment and a second subcompartment, the divider comprising a first material and the elongated body comprising a second material, the first material being relatively more rigid than the second material, the first subcompartment and the subsecond compartment each to accommodate blood pack components.
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This patent claims priority to U.S. Provisional Patent Application No. 61/301,687 filed Feb. 5, 2010, which is hereby incorporated herein by reference in its entirety.
TECHNICAL FIELDThe present patent pertains to containers and, more particularly, to medical containers for use in blood collection and processing and medical systems, methods and apparatus for use in blood collection and processing.
BACKGROUNDBlood packs may be used during blood collection and/or processing. A blood pack may include a needle fluidly coupled to a primary blood collection container. Additionally, the blood pack may include a plurality of transfer bags and a container containing a red blood cell preservative solution all, or some of which, may be fluidly coupled to the primary blood collection container. In practice, whole blood may be transferred from a donor via the needle to the primary blood collection container. Once the whole blood has been collected, a plurality of blood packs containing whole blood may be loaded into a centrifuge to separate plasma from red blood cells, for example. Plasma may then be transferred from the primary collection container to one of the transfer bags and the red blood cells may be transferred to another one of the transfer bags after leukoreduction.
Certain examples are shown in the above-identified figures and described in detail below. In describing these examples, like or identical reference numbers are used to identify the same or similar elements. The figures are not necessarily to scale and certain features and certain views of the figures may be shown exaggerated in scale or in schematic for clarity and/or conciseness. Additionally, several examples have been described throughout this specification. Any features from any example may be included with, a replacement for, or otherwise combined with other features from other examples.
The examples described herein relate to medical containers in which blood packs may be conveniently stored and/or protected during blood collection and processing. In contrast to known techniques, the examples described herein reduce and/or eliminate the need for off-chart recording. The examples described herein enable blood packs to be balanced using portions of the medical containers themselves, thereby expediting the balancing process prior to centrifugation. The medical containers described herein are sized and/or shaped to correspond to cups of known centrifuges. Such an approach of having the medical containers sized to correspond to the cups of known centrifuges, increases the speed in which blood packs may be loaded and/or unloaded into centrifuges and/or processed generally. Additionally, because the blood packs are housed at least partially within the example medical containers during a majority of blood collecting and processing, accidents are less likely to occur in which a blood pack breaks and/or an interface between red blood cells and plasma is disrupted during handling and/or centrifugation.
Example triage systems are described in which the example medical containers may be automatically sorted based on information on the medical containers. By automatically sorting the medical containers, blood centers may more efficiently identify blood that has less time until expiration.
Example expressors are described in which the example medical containers may be positioned and compressed to force different blood components from the bags contained therein. By compressing the medical container itself, the bag containing whole blood may not have to be removed from the medical container during processing. Additionally or alternatively, the example expressors may include a pump that pumps red blood cells through a filter during a leukoreduction process.
The lid 104 may be removably coupled to a surface 110 of the elongated body 106 to substantially prevent contaminates from entering the medical container 100, for example. The lid 104 may be made of any suitable material such as an aluminum lidding foil or a plastic material and may be removably coupled to the elongated body 106 by an adhesive (e.g., sealing lacquer) or by heat sealing, for example. In practice, a person may grasp a tab 112 of the lid 104 and exert a force in a direction generally represented by arrow 114 to remove the lid 104 from the medical container 100. While the medical container 100 of
To separate a first storage compartment 212 from a second storage compartment 214, the medical container 100 includes a divider or middle frame 216. The divider 216 may be made of a relatively rigid material and may extend toward and be coupled to the base 102 to increase the structural rigidity of the medical container 100.
In some examples, a plurality of straps 218 may retain the container 206 in the first storage compartment 212 and may retain the plurality of transfer containers, the filter and the container containing the preservative solution in the second storage compartment 214. Additionally, the straps 218 may be utilized as a handle to move and/or carry the medical container 100 during blood collection and/or processing, for example.
To enable access to the second storage compartment 214 during blood processing, the elongated body 106 defines a perforation and/or tearable portion (e.g., a breakaway portion) 220. To detach or partially detach a portion or section 222 of the elongated body 106 from the medical container 100, a person may exert a force on the portion 222 in a direction generally represented by arrow 224 to initiate a tear adjacent the perforation 220. Once initiated, the person may continue to detach the portion 222 along the perforation 220, thereby providing access to the second storage compartment 214.
Additionally or alternatively, to enable the weight of the medical container 100 containing blood to be relatively easily and/or quickly balanced with another container (not shown) containing blood prior to centrifugation, the elongated body 106 may include a plurality of removable tabs 504 adjacent the surface 110. The removable tabs 504 may have a predetermined weight of approximately 1.0 grams; however, any other suitable weight may be used instead (e.g., 0.5 grams, 1.0 grams, 1.5, grams, etc.). All of the removable tabs 504 may have similar weights or some or all of the removable tabs 504 may have different weights. A perforation or tearable portion 506 may at least partially surround each of the removable tabs 504 to enable the tabs 504 to be relatively easy removed.
The processing label 604 may include a bar code 606 and a portion 608 where additional information may be included and/or written, for example. Some information that may be included on the processing label 604 may be the time that the blood was collected, the start time of blood collection, the end time of blood collection, an identifier associated with an operator (e.g., a nurse), a donor identification number (DIN), donor gender and/or weight of the blood collected, for example. The processing label 604 may include a plurality identical portions that may be removed and/or pealed off and affixed to another container (e.g., a transfer bag), for example.
In practice, an operator (e.g., a nurse or technician) may initially enter information associated with the donor, the operator and/or the blood collection into the apparatus 700. In some examples, this information may be entered into a computer, processor or other data entry device 714 communicatively coupled to the apparatus 700. While the computer 714 is depicted as separate from the apparatus 700, the computer 714 may be incorporated into the apparatus 700 and/or the apparatus 700 may not be provided with the computer 714. The operator may then remove the lid 104 (
After the needle 204 has been inserted into a donor's arm 712, blood may begin to flow through the tube 208 and into the container 206 and the plate 708 may move and/or agitate, thereby mixing the anticoagulant with the blood. In some examples, the blood may be pumped from the donor's arm 712 using a pump 804 (e.g., peristaltic pump) that may be communicatively coupled the apparatus 700. To monitor the pressure (e.g., vein pressure) of the blood flowing through the tube 208, the apparatus 700 may include a sensor (e.g., a pressure sensor) 805 that may be communicatively coupled to the apparatus 700. Depending on the pressure sensed by the sensor 805 and communicated to the apparatus 700, a signal may be transmitted to the pump 804 to change (e.g., increase or decrease) the rate at which blood is pumped from the donor's arm 712, for example.
As the blood enters the container 206, the weight scale 706 weighs the medical container 100 and the computer 714 and/or the apparatus 700 may determine whether or not a predetermined weight has been achieved. In other examples, the pump 804 may convey to the apparatus 700 the amount of blood that has been pumped and the computer 714 and/or the apparatus 700 may determine whether or not a predetermined amount and/or volume of blood has been collected. The predetermined weight and/or volume of blood may be associated with an amount of blood that a donor is to donate. If the computer 714 and/or the apparatus 700 determines that the predetermined weight has been achieved, a signal may be transmitted to the clamp 802 causing the clamp 802 to close, thereby preventing additional blood from being collected from the donor (e.g., preventing over-collection of whole blood), for example. The operator may then remove the needle 204 from the donor's arm 712 and press a button 718 initiating the printer 704 to print a processing label 806. Once printed, the processing label 806 may be affixed to the medical container 100. The use of the processing label 806 decreases and/or eliminates the need for off-chart recording because the information is contained on the processing label 806.
The plurality of medical containers 100 may be secured to the conveyor 902 using an interaction between the notch 108 and locks or L-shaped locks (not shown) coupled to the conveyor 902. As the plurality of medical containers 100 move along the conveyor 902 in a direction generally represented by arrow 908, the scanner 904 scans a bar code 910 on the processing label 806 to determine when blood 912 was collected, for example. Based on when the blood was collected, the sorter 906 sorts the medical containers 100 such that higher priority medical containers 100 (e.g., less time until blood expiration) are processed sooner and/or identified to be processed sooner while lower priority medical containers 100 (e.g., more time until blood expiration) are processed later and/or identified to be processed later. Such an approach, effectively and automatically triages blood packs as they enter a blood center, for example.
The loading station 1202 includes a base 1216 having a lock or L-shaped lock 1218 that corresponds to the notch 108 to secure the medical container 100 relative to the expressor 1200. A portion 1220 of the loading station 1202 may pivot in a direction generally indicated by arrow 1222 to compress the medical container 100 to remove blood components (e.g., plasma or RBCs) from the container 206. The portion 1220 may be spring loaded and may be rotated and/or moved using any mechanical device (e.g., a motor, an actuator) (not shown). Additionally or alternatively, the loading station 1202 may include a sensor 1224 that may read a portion of the processing label 604 (e.g., the bar code 606) to identify information associated with the particular medical container 100, for example.
Turning to
A sensor 1418 (e.g., a hematocrit sensor, a light sensor, an opaque sensor, a light density sensor or any other type of sensor that can determine light density of the fluid) communicatively coupled to the clamps 1211, 1212 and/or 1213 may be positioned adjacent the tube 1412 to detect whether plasma or RBCs are flowing through the tube 1412, for example. Once the sensor 1418 detects RBCs flowing through the tube 1412, a signal may be conveyed to the first clamp 1211 to close substantially preventing additional fluid flow through the tube 1416 to the first transfer bag 1402 and for the second clamp 1212 to open enabling the preservative solution to flow from the container 1404 through the tubes 1408, 1412 and 1414 to the container 206. As the preservative solution flows into the container 206, the preservative solution may mix with the RBCs. The preservative solution may be Adosol®, E-SOL or any other suitable additive.
After the preservative solution has been added to the container 206, the second clamp 1212 may close substantially preventing additional fluid flow through the tube 1414 and third clamp 1213 may open enabling fluid flow through the tube 1410. A pump (not shown) and/or the portion 1220 may further compress the container 206 through the medical container 100 to flow the RBCs through a filter (a leukocyte filter) 1420 and then through the tubes 1408 and 1410 to be stored in the second transfer bag 1406. Because the elongated body 106 is made of a relatively flexible material, the portion 1220 may compress the container 206 through the medical container 100 itself, thereby eliminating the need to remove the container 206 from the medical container 100. After the RBCs have been transferred through the filter 1420 to the second transfer bag 1406, the printer 1214 may print a label(s) (one of which is represented by reference number 1422) using information obtained from the processing label 604, for example. The label may then be affixed to the first transfer bag 1402, for example.
As discussed above, once the medical container 150 is secured in the loading station 1602 and transfer bags 1624 and 1626 and a container 1628 containing preservative solution are hung from the respective hangers 1604-1608, a portion (e.g., similar to the portion 1220) of the loading station 1602 may be moved and/or extended to compress the container 206 against the divider 216 pushing plasma from the container 206. Because initially the second clamp 1616 may be closed preventing fluid flow to the container 1628 and the first clamp 1614 may be open, the plasma may flow into one of the transfer bags 1624 and 1626.
A sensor 1630 communicatively coupled to the clamps 1614 and/or 1616 may be positioned adjacent a tube 1632 to detect whether plasma or RBCs are flowing through the tube 1632, for example. Once the sensor 1630 detects RBCs flowing through the tube 1632, a signal may be conveyed to the first clamp 1614 to close substantially preventing additional fluid flow to the transfer bags 1624 and 1626 and for the second clamp 1616 to open enabling the preservative solution to flow from the container 1628 to the container 206. As the preservative solution flows into the container 206, the preservative solution may mix with the RBCs.
After the preservative solution has been added to the container 206, the container 206 may be removed from the medical container 150 and hung from the hanger 1610. Tubes (not shown) may be positioned adjacent the pump 1620 that moves (e.g., rotates) to urge the RBCs through a filter (not shown) (e.g., a leukocyte filter) and into another transfer bag (not shown) fluidly coupled to the container 206. Additionally, another tube (not shown) may be positioned adjacent the sensor 1622 to enable the sensor 1622 to sense the pressure of the blood flowing from the container 206 to the transfer bag and, thus, to enable the rate at which the pump 1620 pumps the RBCs from the container 206 to be adjusted accordingly. After the leukoreduction process is complete, the printer 1618 may print a label(s) (one of which is represented by reference number 1634) using information obtained from the processing label 604, for example. The label may then be affixed to the transfer bags 1624 and/or 1626 and/or the transfer bag containing RBCs, for example.
In operation, after the plasma has been removed from the container 1712 in a process as described above, for example, the container 1712 may be removed from the medical container (e.g., similar to medical container 100 and/or 150) and hung on a hanger 1736. The first tube 1714 may then be positioned adjacent the pump 1706 and the fourth tube 1720 may be positioned adjacent the sensor 1710. As shown in
The flow diagrams depicted in
Turning to
The operator may then insert the needle 204 (
However, if the apparatus 700 (
Turning to
Turning to
The operator may then remove at least some of the containers (e.g., the first transfer bag 1402, the container 1404 containing preservative solution and the second transfer bag 1406) from the medical container 100 (
The expressor 1200 (
However, if red blood cells are detected, control advances to block 2520 and additional fluid flow is prevented to the container containing plasma (block 2520). To prevent additional fluid flow to the container containing plasma, a signal may be conveyed to the first clamp 1211 to close, thereby substantially preventing additional fluid flow through the tube 1416 to the first transfer bag 1402. Additionally, a signal may be conveyed to the second clamp 1212 causing the second clamp 1212 to open enabling the preservative solution to flow from the container 1404 through the tubes 1408, 1412 and 1414 into the primary blood collection container 206 (
The expressor 1200 (
Turning to
However, if the expressor 1700 (
Although certain example methods, apparatus and articles of manufacture have been described herein, the scope of coverage of this patent is not limited thereto. On the contrary, this patent covers all methods, apparatus and articles of manufacture fairly falling within the scope of the appended claims either literally or under the doctrine of equivalents.
Claims
1. A medical container configured to accommodate blood pack components during blood collection and processing, the medical container comprising:
- an elongated body extending between first and second ends and defining a compartment;
- a base fixedly secured to the first end of the elongated body;
- a substantially planar divider extending through the compartment from the base to the second end of the elongated body to separate the compartment into a first subcompartment and a second subcompartment, the divider comprising a first material, the elongated body comprising a second material, and the base comprising a third material, the first and third materials being generally rigid and the second material being generally flexible, and the first subcompartment and the second subcompartment each being configured to accommodate blood pack components; and
- blood pack components comprising a primary blood collection container and one or more of a needle, one or more transfer bags, a leukocyte filter, or a container containing a preservative solution, wherein one or more of the blood pack components are fluidly coupled together, with the primary blood collection container being at least partially positioned in the first subcompartment and said one or more of the needle, the one or more transfer bags, the leukocyte filter, or the container containing the preservative solution being positioned in the second subcompartment.
2. The medical container of claim 1, wherein the divider is coupled to the base to increase the structural rigidity of the medical container.
3. The medical container of claim 2, wherein a portion of the elongated body is sufficiently deformable to be deformed toward the divider during a blood processing procedure.
4. The medical container of claim 1 configured for receipt within a centrifuge receptacle during blood processing, the medical container having a shape that is complementary to a shape of the centrifuge receptacle.
5. The medical container of claim 1, wherein the base further comprises a fixture to enable the medical container to be secured to another apparatus.
6. The medical container of claim 5, wherein the fixture comprises a slot to receive an L-shaped lock of the apparatus.
7. The medical container of claim 5, wherein the apparatus comprises at least one of a blood collection apparatus, or a plasma expressor used during blood processing.
8. The medical container of claim 1, further comprising a lid removably coupled at a second end of the elongated body, the lid to substantially prevent contaminants from entering the compartment.
9. The medical container of claim 8, wherein the lid comprises at least one of an aluminum lidding foil or plastic.
10. The medical container of claim 8, wherein the lid comprises a tab to facilitate removing the lid from the elongated body.
11. The medical container of claim 1, wherein the elongated body comprises one or more removable tabs to facilitate balancing the medical container with another medical container prior to centrifugation.
12. The medical container of claim 1, wherein the second material comprises at least one of a foil based material or a plastic material.
13. The medical container of claim 1, further comprising one or more straps coupled adjacent to a second end of the elongated body.
14. The medical container of claim 13, wherein the one or more straps are to secure the blood pack components within the first and second compartments.
15. The medical container of claim 13, wherein the one or more straps are to facilitate handling the medical container.
16. The medical container of claim 1, wherein the elongated body comprises a tearable portion to enable removal of one or more of the blood pack components from the second compartment.
17. The medical container of claim 1, wherein the elongated body comprises a transparent portion to enable a fluid level within the primary collection bag of the blood pack components to be identified.
18. The medical container of claim 1, further comprising a processing label to be affixed to the medical container in a location being exempt from regulatory requirements, the processing label comprising a machine readable portion and a human readable portion.
19. The medical container of claim 18, the machine readable portion to be scanned by a plasma expressor to facilitate printing other processing labels to be affixed to one or more transfer bags of the blood pack components after blood component separation, the other processing labels complying with regulatory requirements.
20. The medical container of claim 18, the machine readable portion to be scanned by a scanner of a triage system to facilitate triaging the medical container based on a priority level.
21. The medical container of claim 18, wherein the processing label is printed by at least one of a blood collection apparatus and a plasma expressor during the blood collection and processing.
22. The medical container of claim 1, further comprising a processing label to be affixed to the medical container in a location complying with regulatory requirements.
23. A medical container comprising:
- an elongated body defining a compartment;
- a base coupled at a first end of the elongated body;
- a divider extending through the compartment to separate the compartment into a first subcompartment and a second subcompartment, the divider comprising a first material and the elongated body comprising a second material, the first material being generally rigid and the second material being generally flexible, and the first subcompartment and the second subcompartment each being configured to accommodate blood pack components; and
- blood pack components comprising a primary blood collection container and one or more of a needle, one or more transfer bags, a leukocyte filter, or a container containing a preservative solution, wherein one or more of the blood pack components are fluidly coupled together, with the primary blood collection container being at least partially positioned in the first subcompartment and said one or more of the needle, the one or more transfer bags, the leukocyte filter, or the container containing the preservative solution being positioned in the second subcompartment.
24. The medical container of claim 23, wherein the divider is coupled to the base to increase the structural rigidity of the medical container.
25. The medical container of claim 24, wherein a portion of the elongated body is sufficiently deformable to be deformed toward the divider during a blood processing procedure.
26. The medical container of claim 23 configured for receipt within a centrifuge receptacle during blood processing, the medical container having a shape that is complementary to a shape of the centrifuge receptacle.
27. The medical container of claim 23, wherein the base further comprises a fixture to enable the medical container to be secured to another apparatus.
28. The medical container of claim 27, wherein the fixture comprises a slot to receive an L-shaped lock of the apparatus.
29. A medical container configured to accommodate blood pack components and to be used in combination with at least one of a blood collection apparatus, a plasma expressor, and/or a conveyor during blood collection and processing, the medical container comprising:
- an elongated body defining a compartment, the compartment being configured to accommodate blood pack components a divider extending through the compartment to separate the compartment into a first subcompartment and a second subcompartment;
- a base coupled at a first end of the elongated body and an open or openable end at the opposite end of the elongated body, the base comprising a fixture to enable the medical container to be secured relative to at least one of a blood collection apparatus, a plasma expressor, and/or a conveyor during the blood collection and processing, wherein the fixture comprises a slot defined in the base and having a generally vertical portion associated with a bottom surface of the base and a generally horizontal portion associated with the generally vertical portion and spaced away from the bottom surface of the base, wherein the generally vertical portion of the slot extends to the perimeter of the base and a portion of the base is positioned between the perimeter of the base and the generally horizontal portion of the slot, such that the generally horizontal portion of the slot is spaced away from the perimeter of the base; and
- blood pack components comprising a primary blood collection container and one or more of a needle, one or more transfer bags, a leukocyte filter, or a container containing a preservative solution, wherein one or more of the blood pack components are fluidly coupled together, with the primary blood collection container being at least partially positioned in the first subcompartment and said one or more of the needle, the one or more transfer bags, the leukocyte filter, or the container containing the preservative solution being positioned in the second subcompartment.
30. The medical container of claim 29, wherein the fixture is configured to receive an L-shaped lock of the at least one of the blood collection apparatus, the plasma expressor, or the conveyor of associated with the triage system.
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Type: Grant
Filed: Feb 4, 2011
Date of Patent: Nov 4, 2014
Patent Publication Number: 20110192745
Assignee: Fenwal, Inc. (Lake Zurich, IL)
Inventor: Kyungyoon Min (Kildeer, IL)
Primary Examiner: Luan K Bui
Assistant Examiner: Rafael Ortiz
Application Number: 13/021,310
International Classification: B65D 69/00 (20060101); B65D 71/00 (20060101); A61J 1/10 (20060101); A61M 1/02 (20060101); A61M 1/36 (20060101);